European Medicines Agency (EMA) Clinical Trials This is an RSS file. You can use it to subscribe to this data in your favourite RSS reader or to display this data on your own website or blog.

Experiences and challenges with the new European Clinical Trials Regulation
ConclusionsCTIS promised to lower the administrative bar, but unfortunately this has not been achieved. There are challenges that need to be urgently confronted and addressed for international research collaborators to effectively manage health crises in the future. While the value of multi-national outbreak research is clear, the limitations and delays imposed by the system, which raise challenging ethical questions about the regulation, are prejudicial to all clinical research, especially publicly funded academic studies. This report is relevant to both regulators and clinical researchers. It is hoped that these findings...
Source: Trials - January 2, 2024 Category: Research Source Type: clinical trials

Libtayo Receives Positive CHMP Opinion Recommending Approval to Treat Advanced Cervical Cancer
TARRYTOWN, N.Y., Oct. 14, 2022. Regeneron Pharmaceuticals, Inc. today announced the European Medicines Agency ' s (EMA) Committee for Medicinal Products for Human Use (CHMP) has adopted a positive opinion for Libtayo (cemiplimab) as a monotherapy for... (Source: Drugs.com - Clinical Trials)
Source: Drugs.com - Clinical Trials - October 14, 2022 Category: Pharmaceuticals Source Type: clinical trials

AbbVie Submits Regulatory Applications to FDA and EMA for Rinvoq in Crohn's Disease
NORTH CHICAGO, Ill., July 27, 2022. AbbVie today announced that it has submitted applications for a new indication to the U.S. Food and Drug Administration (FDA) and European Medicines Agency (EMA) for upadacitinib (Rinvoq 45 mg [induction dose] and... (Source: Drugs.com - Clinical Trials)
Source: Drugs.com - Clinical Trials - July 27, 2022 Category: Pharmaceuticals Source Type: clinical trials

PragmaTic, prospEctive, randomized, controlled, double-blind, mulTi-centre, multinational study on the safety and efficacy of a 6% HydroxYethyl Starch (HES) solution versus an electrolyte solution in trauma patients: study protocol for the TETHYS study
DiscussionThis pragmatic study will increase the evidence on safety and efficacy of 6% HES 130 for treatment of hypovolemia secondary to acute blood loss in trauma patients.Trial registrationRegistered in EudraCT, No.: 2016-002176-27 (21 April 2017) and ClinicalTrials.gov, ID:NCT03338218 (09 November 2017). (Source: Trials)
Source: Trials - June 2, 2022 Category: Research Source Type: clinical trials

Prospective, randomized, controlled, double-blind, multi-center, multinational study on the safety and efficacy of 6% Hydroxyethyl starch (HES) sOlution versus an Electrolyte solutioN In patients undergoing eleCtive abdominal Surgery: study protocol for the PHOENICS study
This study was requested by the European Medicines Agency (EMA) to provide more evidence on the long-term safety and efficacy of HES solutions in the perioperative setting.MethodsPHOENICS is a randomized, controlled, double-blind, multi-center, multinational phase IV (IIIb) study with two parallel groups to investigate non-inferiority regarding the safety of a 6% HES 130 solution (Volulyte 6%, Fresenius Kabi, Germany) compared with a crystalloid solution (Ionolyte, Fresenius Kabi, Germany) for infusion in patients with acute blood loss during elective abdominal surgery. A total of 2280 eligible patients (male and female pa...
Source: Trials - February 22, 2022 Category: Research Source Type: clinical trials

Outcome selection for tissue-agnostic drug trials for immune-mediated inflammatory diseases: a systematic review of core outcome sets and regulatory guidance
ConclusionsThe findings from this systematic review provide valuable information to inform outcome selection in tissue-agnostic trials for IMIDs. There is a need for increased collaboration between regulators and COS developers and inclusion of regulators as key stakeholders in COS development to enhance the quality of COS.Trial registrationNot registered. (Source: Trials)
Source: Trials - January 15, 2022 Category: Research Source Type: clinical trials

Positive EMA opinion for the use of Teysuno in metastatic colorectal cancer
HOOFDDORP, The Netherlands, Jan. 4, 2022. Nordic Pharma has announced that on 16 December 2021, the Committee for Medicinal Products for Human Use (CHMP) adopted a positive opinion Teysuno: Pending EC decision | European Medicines Agency... (Source: Drugs.com - Clinical Trials)
Source: Drugs.com - Clinical Trials - January 4, 2022 Category: Pharmaceuticals Source Type: clinical trials

Novavax and Serum Institute of India Announce World Health Organization Grants Emergency Use Listing for NVX-CoV2373 COVID-19 Vaccine
First EUL granted by WHO for a protein-based COVID-19 vaccine EUL vaccine manufactured and marketed by SII as COVOVAX™ WHO EUL for Nuvaxovid™ currently under assessment; will be completed following European Medicines Agency (EMA)... (Source: Drugs.com - Clinical Trials)
Source: Drugs.com - Clinical Trials - December 17, 2021 Category: Pharmaceuticals Source Type: clinical trials

Kineret (anakinra) receives positive opinion from the CHMP for treatment of patients with COVID-19 pneumonia
STOCKHOLM, Dec. 16, 2021. Swedish Orphan Biovitrum AB today announces that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has adopted a positive opinion of Kineret (anakinra) for the treatment of... (Source: Drugs.com - Clinical Trials)
Source: Drugs.com - Clinical Trials - December 16, 2021 Category: Pharmaceuticals Source Type: clinical trials

Long-Term Observational Study on Effectiveness and Safety of Lecigon in Patients With Advanced Parkinson's Disease
Condition: Advanced Parkinson Disease Intervention: Combination Product: Lecigon® based on European Medicines Agency (EMA) SmPC Sponsor: Britannia Pharmaceuticals Ltd. Recruiting (Source: ClinicalTrials.gov)
Source: ClinicalTrials.gov - September 14, 2021 Category: Research Source Type: clinical trials